Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center phase 2 trial evaluates if combining osimertinib with LINAC-based stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (SRT) improves intracranial control and survival in adults with stage IV NSCLC and symptomatic brain metastases bearing sensitizing EGFR mutations (exon 19 deletion or exon 21 L858R). Participants continue osimertinib at 80 mg daily and receive SRS (one fraction) or SRT (3–5 fractions) to brain lesions. Primary outcomes include intracranial objective response by RANO-BM criteria and progression-free and overall survival, along with treatment-related adverse events. The trial is designed to provide prospective data on the safety and efficacy of adding LINAC-based local therapy to EGFR-TKI in Southeast Asian patients, specifically in Vietnam. Endpoints also consider extracranial disease control per RECIST 1.1.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* ECOG performance status 0-2.
* Histologically confirmed adenocarcinoma or squamous cell carcinoma of the lung, stage IV (AJCC 8th edition).
* Sensitizing EGFR mutation: exon 19 deletion or exon 21 L858R point mutation.
* Brain metastases diagnosed on contrast-enhanced MRI, CT or 18F-FDG PET-CT.
* Symptomatic brain metastases: brain metastases accompanied by neurological symptoms, either (a) present at diagnosis of brain metastases, or (b) arising while the patient is receiving osimertinib. Qualifying symptoms: raised intracranial pressure (headache, nausea/vomiting); focal neurological deficits (limb weakness or paralysis, sensory disturbance, visual disturbance, language disturbance, seizure, imbalance); cognitive-behavioural changes (memory or concentration decline, personality or mood change).
* 1 to 4 brain metastases, each 4 cm or smaller in maximum diameter.
* Written informed consent.

Exclusion Criteria:

* History of a second malignancy.
* Pregnancy.
* Asymptomatic brain metastases (no neurological symptoms).
* Leptomeningeal metastases.
* Prior treatment with a first- or second-generation EGFR-TKI.
* Prior stereotactic radiosurgery or whole-brain radiotherapy.
* Discontinuation of osimertinib before completing at least 3 months of treatment.

Where it's running

• Cho Ray Hospital - Department of Medical and Radiation Oncology, Oncology Center
  Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Principal investigator: HUNG HA GIA NGUYEN, MD, MSc — Cho Ray Hospital
• Study coordinator: HUNG HA GIA NGUYEN, MD, MSc
• Email: NHGHUNG@GMAIL.COM
• Phone: +84 978404343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining osimertinib and dalpiciclib for advanced lung cancer after treatment resistance

  This study is testing if combining two drugs, osimertinib and dalpiciclib, can help people with advanced lung cancer who have not responded to other treatments.

  Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT06363734

• Evaluating molecular factors and resistance mechanisms in lung cancer treatment

  This study is testing how well a specific lung cancer treatment works for patients with certain gene mutations and aims to find out why some patients might not respond to the treatment or have a relapse.

  Recruiting at 36 sites Intergroupe Francophone de Cancerologie Thoracique · Angers and 35 other locations · NCT06053099

• Izalontamab Brengitecan with Osimertinib in EGFR-mutant NSCLC: first-line versus standard options

  This study tests whether adding iza-bren to osimertinib can help people with newly diagnosed EGFR-mutant non-small cell lung cancer, compared with osimertinib alone or osimertinib plus platinum-based chemotherapy.

  Recruiting at 10 sites Phase 3 Bristol-Myers Squibb · Beverly Hills, California and 204 other locations · NCT07680790

• BL-B01D1 with Osimertinib before/around surgery for EGFR-mutant resectable NSCLC

  A Phase II/III trial tests if adding BL-B01D1 to osimertinib around surgery helps people with resectable EGFR-mutant non-small cell lung cancer.

  Recruiting at 2 sites Phase 2/3 Sichuan Baili Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality and 1 other locations · NCT07642024

• Barriers and facilitators to sticking with osimertinib after early-stage NSCLC

  This study asks how adults with early-stage NSCLC in China continue or stop adjuvant osimertinib, by talking with patients and doctors to understand what helps or hinders persistence.

  Recruiting AstraZeneca · Beijing · NCT07542210

• Ivonescimab with datopotamab deruxtecan or osimertinib for EGFR‑mutant non‑small cell lung cancer

  This trial will test whether combining ivonescimab with datopotamab deruxtecan or with osimertinib is safe and helps people with metastatic EGFR‑mutant non‑small cell lung cancer who have already received third‑generation EGFR inhibitors and chemotherapy.

  Recruiting at 7 sites Phase 1/2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07535437

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.